đź“‹ FDA Reference
long-term hemodialysis catheters with biobloc coating
Bard Access Systems
Summary: The long-term hemodialysis catheters with biobloc coating by Bard Access Systems are used for hemodialysis in patients requiring long-term vascular access. They are typically used by nephrologists and dialysis specialists.
FDA Clearance Information
Pathway 510K
Number K053589 ↗
Decision Date April 13, 2006
Product Code MSD
Device Class Class 2
Evidence 0 studies
This device was cleared through the FDA 510(k) pathway on April 13, 2006. Manufactured by Bard Access Systems, it is classified as a Class 2 medical device under product code MSD.
What It Is
The long-term hemodialysis catheters with biobloc coating are specialized catheters designed for patients who require prolonged vascular access for hemodialysis. The biobloc coating is intended to reduce the risk of infection and improve the longevity of the catheter. These catheters are inserted into large veins, typically in the neck or chest, to facilitate efficient blood flow during dialysis sessions.
Clinical Applications
These catheters are commonly used in patients with chronic kidney disease who require regular hemodialysis. They are typically utilized in hospital settings, dialysis centers, or outpatient clinics. Nephrologists and interventional radiologists are the primary specialists involved in the insertion and management of these catheters. The device is particularly useful for patients who do not have suitable arteriovenous fistulas or grafts.
Indications for Use
The FDA indications for this device include providing long-term vascular access for hemodialysis in patients with end-stage renal disease. It is intended for use in patients who require regular dialysis but do not have other viable access options.
Practical Considerations
These catheters come in various sizes to accommodate different patient anatomies and are compatible with standard dialysis equipment. Proper insertion technique and maintenance are crucial to minimize complications such as infection or thrombosis. Regular monitoring and care are essential to ensure the catheter remains functional over time.
Frequently Asked Questions
What is long-term hemodialysis catheters with biobloc coating used for?
These catheters are used for providing long-term vascular access for hemodialysis in patients with chronic kidney disease.
What specialties typically use this device?
Nephrologists and interventional radiologists typically use these catheters, often in dialysis centers or hospital settings.
What are the FDA-cleared indications?
The catheters are indicated for long-term vascular access for hemodialysis in patients with end-stage renal disease.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.